MenorrhagiaNCT01569763
Minerva Pivotal Study to Evaluate Safety and Efficacy of the Aurora Endometrial Ablation System Compared to Hysteroscopic Rollerball Ablation
A study testing Aurora Endometrial Ablation and Rollerball Ablation/Resection in people with Menorrhagia, run by Minerva Surgical, Inc. at 13 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Aurora Endometrial Ablation and Rollerball Ablation/Resection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Mar 2012to 2 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Refractory menorrhagia with no definable organic cause
- Female subject from (and including) age 25 to 50 years
- Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm
- A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR,
- A minimum menstrual blood loss of ≥ 160 ml for one baseline cycle for women who either
- had at least 3 prior months documented failed medical therapy; or
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- had a contraindication to medical therapy
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
- Not pregnant and no desire to conceive at any time
- Subject agrees to use a reliable form of contraception up to the 12-month follow-up visit. If a hormonal birth control method is used for contraception, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through the initial 12-month follow-up
- Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
- Subject agrees to follow-up exams and data collection requirements
- Subject who is literate or demonstrates an understanding on how to collect menstrual blood loss products for the alkaline hematin method of analysis
Who cannot join
- Pregnancy or subject with a desire to conceive
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD)
- Presence of bacteremia, sepsis, or other active systemic infection
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- Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
- Known/suspected abdominal pelvic or gynecological malignancy within the past 5 years
- Known clotting defects or bleeding disorders
- Untreated/unevaluated cervical dysplasia, except CIN I
- Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
- Previous endometrial ablation procedure
- Presence of an implantable (intrauterine) contraceptive device (e.g. Essure™ or Adiana™)
- Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
- Currently on anticoagulants
- Abnormal or obstructed cavity as confirmed by hysteroscopy, SIS or vaginal ultrasound
- Presence of an intrauterine device (IUD) which the Subject is unwilling to have removed at the time of the operative visit
- Subject currently on hormonal birth control therapy (including the Mirena device) for <3 months prior to enrollment
- Subject who is unwilling to use birth control post-ablation whether non-hormonal birth control or the same hormonal birth control therapy as before the procedure
- Subject who is within 6-weeks post partum
- Any subject who is currently participating or considers future participation in a research study of an investigational drug or device during the course of this investigational study
- Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States8 sites
New Horizons Women's Care
Chandler, Arizona, 85224
Minnesota Gynecology and Surgery
Edina, Minnesota, 55435
Baylor Research Institute
Fort Worth, Texas, 76104
Tennessee Women's Care PC
Nashville, Tennessee, 37203
Basinski, LLC
Newburgh, Indiana, 47630
Women's Health Research
Phoenix, Arizona, 85015
Mercy Clinic Minimally Invasive Gynecology
St Louis, Missouri, 63141
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
Canada4 sites
McMaster University/Hamilton Health Sciences
Hamilton, Ontario, L8N3Z5
La Cite Medicale
Québec, Quebec, G1W 2J5
Regina Qu'Appelle Health Region
Regina, Saskatchewan, S4S 6X3
Hôpital LaSalle
Ville Lassalle, Quebec, H8P 1C1
About this study
Official title: Minerva Pivotal Study
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.
Read the detailed description
Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage typically provides relief for only a few menstrual cycles. Traditionally hysterectomy has been the definitive treatment for menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom childbearing is complete. Subjects who are randomized to the control group will receive hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be treated with the Aurora Endometrial Ablation System.
- Conditions
- Menorrhagia
- Being tested
- Aurora Endometrial Ablation, Rollerball Ablation/Resection
- Keywords
- endometrial ablation
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurora Endometrial AblationDevice
Endometrial Ablation using the Aurora Endometrial Ablation system
Rollerball Ablation/ResectionDevice
Hysteroscopic rollerball resection/ablation
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopic rollerball resection/ablation | Active comparator | Not described Receives: Device: Rollerball Ablation/Resection |
| Aurora Endometrial Ablation | Experimental | Not described Receives: Device: Aurora Endometrial Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months
Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.
Measured: 12 months
Secondary outcomes (1)
Procedure Time
Procedure time is defined as the time from device insertion to time of device removal.
Measured: < 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2015
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minerva Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Skalnyi, MD, Study director, Minerva Surgical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569763
- Sponsor's protocol ID
- CIP0005
- Status last verified
- Mar 2018
- First submitted
- 30 Mar 2012
- Last updated
- 18 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minerva Pivotal Study
- ClinicalTrials.gov ID
- NCT01569763
- Acronym / sponsor ID
- CIP0005
- Conditions
- Menorrhagia
- Keywords
- endometrial ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Minerva Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and effectiveness of the Aurora Endometrial Ablation System as compared to hysteroscopic rollerball endometrial ablation in reducing menstrual blood loss at 12 months post-treatment.
Detailed description
Menorrhagia is defined as menstrual bleeding in the ovulatory woman exceeding 80 ml per month. Approximately 20-25% of healthy premenopausal women have abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage typically provides relief for only a few menstrual cycles. Traditionally hysterectomy has been the definitive treatment for menorrhagia. This clinical study evaluates the safety and effectiveness of the Aurora Endometrial Ablation System to provide a therapeutic treatment for menorrhagia due to benign causes by ablating the endometrial lining of the uterus in pre-menopausal women for whom childbearing is complete. Subjects who are randomized to the control group will receive hysteroscopic rollerball/resection ablation. Subjects randomized to the test arm will be treated with the Aurora Endometrial Ablation System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hysteroscopic rollerball resection/ablation | Active comparator | Device: Rollerball Ablation/Resection |
| Aurora Endometrial Ablation | Experimental | Device: Aurora Endometrial Ablation |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Refractory menorrhagia with no definable organic cause
- Female subject from (and including) age 25 to 50 years
- Uterine sound measurement of no greater than10.0cm (external os to internal fundus) and a minimum uterine cavity length of 4.0cm
- A minimum menstrual blood loss of ≥ 160 ml for two baseline cycles within three months prior to treatment as measured by alkaline hematin extraction; OR,
- Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
Key exclusion criteria (22 listed)
- Pregnancy or subject with a desire to conceive
- Endometrial hyperplasia as confirmed by histology
- Presence of active endometritis
- Active pelvic inflammatory disease
- Active sexually transmitted disease (STD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurora Endometrial AblationEndometrial Ablation using the Aurora Endometrial Ablation system | Device | Aurora Endometrial Ablation |
| Rollerball Ablation/ResectionHysteroscopic rollerball resection/ablation | Device | hysteroscopic rollerball resection/ablation |
Primary outcome
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months
Time frame: 12 months
Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.
1 secondary outcome
Procedure Time
Time frame: < 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Skalnyi, MD study director
Minerva Surgical, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aurora Endometrial Ablation and Rollerball Ablation/Resection in people with Menorrhagia, run by Minerva Surgical, Inc. at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.